Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D
NCT ID: NCT04074421
Last Updated: 2020-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
240 participants
INTERVENTIONAL
2020-05-10
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Rifaximin group
Repeating treatment of Rifaximin
Rifaximin
A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.
Probiotics group
Sequential treatment of probiotics called Bacillus subtilis and Enterococcus faecium
Probiotic Formula
A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks.
Placebo group
Placebo control group
Placebo oral tablet
Placebo oral tablet that has no therapeutic effect
Interventions
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Rifaximin
A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.
Probiotic Formula
A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks.
Placebo oral tablet
Placebo oral tablet that has no therapeutic effect
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* in line with the diagnostic criteria of diarrhea-type irritable bowel syndrome Roman IV；
* blood routine, blood biochemistry, stool examination and colonoscopy within 2 years are no problem;
* no intestinal warning symptoms
Exclusion Criteria
* suffering from mental disorders caused by schizophrenia, brain organic and physical diseases;
* suffering from other diseases that may affect intestinal function (such as diabetes, thyroid disease);
* History of previous abdominal surgery (excluding history of cholecystectomy or appendectomy);
* pregnant or lactating women;
* have undergone colonoscopy in the past month or accept other bowel preparation operations;
* In the past 1 month, have used antibiotics, antidiarrheal agents, intestinal flora regulation, Chinese medicine and other drugs;
* have participated in other dietary treatments;
* understand communication barriers, unable to communicate
18 Years
85 Years
ALL
No
Sponsors
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Sir Run Run Shaw Hospital
OTHER
The First Affiliated Hospital of Zhejiang Chinese Medical University
OTHER
RenJi Hospital
OTHER
Peking Union Medical College Hospital
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
The Central Hospital of Lishui City
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Liangjing Wang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jian-an The President
Role: primary
Other Identifiers
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(2019) Study No. 413
Identifier Type: -
Identifier Source: org_study_id
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